MID · Class II · 21 CFR 866.5660

FDA Product Code MID: System, Test, Anticardiolipin Immunological

Leading manufacturers include Zeus Scientific, Inc., Inova Diagnostics, Inc. and Corgenix, Inc..

94
Total
94
Cleared
155d
Avg days
1991
Since
94 devices
73–94 of 94
Cleared Aug 20, 1992
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST
K920401
General Biometrics, Inc.
Immunology · 204d
Cleared Aug 03, 1992
DIASTAT ANTI-CARDIOLIPIN KIT
K921265
Shield Diagnostics, Ltd.
Immunology · 140d
Cleared Jun 04, 1992
SYNELISA CARDIOLIPIN ANTIBODIES
K921250
Elias U.S.A., Inc.
Immunology · 80d
Cleared Dec 09, 1991
ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM
K911661
Immuno Concepts, Inc.
Immunology · 241d
Cleared Nov 19, 1991
QUANTA LITE(TM) ACA
K911680
Inova Diagnostics, Inc.
Immunology · 218d